State Office issued with volume procurement "20", special procurement included in the national procurement!

On January 29th, the General Office of the State Council issued the Opinions on Promoting the Normal institutionalization of drug centralized belt procurement, which made an important deployment for the next step in drug belt procurement, starting with seven major aspects, such as clear coverage, improving procurement rules, strengthening safeguards, and perfecting supporting policies, with a total of 20 measures.
combing found that there are six main bright spots: First, should be harvested, eligible drugs to reach a certain number or amount of the first clear scope of collection of drugs, focusing on the basic medical insurance drug catalog of large quantities, procurement of high amount of drugs into the procurement scope, and gradually cover the domestic market clinically necessary, reliable quality of various types of drugs, so that should be harvested.
priority should be given to the procurement of drugs that have been evaluated for the quality and efficacy of generic drugs (including the same as between) and the same technology (hereinafter referred to as consistency evaluation).
quantity or amount of qualified drugs, i.e. to initiate centralized strip procurement.
actively explore the appropriate procurement methods for "orphan medicine" and shortage of medicines to promote the stability of supply.
2. Beyond the agreed procurement volume, the priority procurement of selected products is encouraged to be approved on the basis of reasonable determination of the purchase volume, and the drug procurement base is approved according to the demand reported by the medical institution, combined with the previous year's usage, clinical use status and medical technology progress.
the proportion of procurement is reasonably determined according to the characteristics of clinical use of drugs, the pattern of market competition and the number of selected enterprises, and is raised as far as possible under the premise of ensuring quality and supply and preventing monopoly.
agreed procurement volume is determined according to the procurement volume base and the agreed procurement ratio and is disclosed in the procurement instrument.
public medical institutions are encouraged to purchase selected products in excess of the agreed amount of medicines in real terms, and other appropriately priced registered varieties can also be purchased through the provincial drug centralized procurement platform.
3. The exploration of adaptive or functional treatment of similar generic drugs combined collection in the perfect competition rules clearly: through the consistent evaluation of generic drugs, original research drugs and parameter preparations do not set up quality groups, directly under the generic name of the competition unit to carry out centralized volume procurement, not to set up protective or discriminatory provisions.
to the consistent evaluation of drug varieties not yet covered, we should clarify the procurement quality requirements, explore the establishment of a comprehensive evaluation system based on big data for clinical use, with generic drug grouping in principle not more than 2.
in accordance with the reasonable price relationship, the clinical efficacy of similar drugs with the generic name of the same route of administration of different dosage forms, specifications, packaging and its procurement volume combined to promote competition.
to explore the integration of different generic drugs with similar allergies or functional treatments for centralized volume procurement.
more than 3 generic drugs are evaluated by consistency, the centralized volume procurement will no longer select products that have not passed the conformity evaluation under the premise of ensuring supply.
Fourth, accelerate the formation of a unified and open drug centralized procurement market, the implementation of the network dynamic trustworthy incentives and the punishment of failure of trust in improving the function of the centralized drug procurement platform, provincial drug centralized procurement agencies should rely on the centralized drug procurement platform, based on medical insurance payments, under the leadership of the drug centralized procurement authorities, tender, procurement, transactions, settlement management, improve transparency.
public medical institutions within the scope of the province shall purchase all the required medicines on the centralized procurement platform of medicines in the province (autonomous region or municipality directly under the Central Government).
Strengthen the standardized construction of a centralized drug procurement platform, unify basic operating rules, work processes and standards for the removal of drug networks, unify the classification and code of medical insurance drugs, unify the information standards for drug procurement, realize inter-provincial drug centralized procurement information interconnection, accelerate the formation of a unified and open centralized drug procurement market, establish and improve the system of evaluation of pharmaceutical prices and credit, and implement dynamic trust-abiding incentives and non-trust and punishment in accordance with the law.
to promote the sharing of information on medical insurance information platform, the national comprehensive management information platform for drug supply guarantee, the regional health information platform for all and the national credit information sharing platform.
, promote the construction of regional and national alliance procurement mechanism in accordance with the requirements of government organizations, alliance procurement, platform operation, promote the construction of regional and national alliance procurement mechanism.
The medical security department shall, together with the relevant departments, guide or organize the relevant regions and medical institutions to form a centralized drug procurement alliance, strengthen coordination of work, deploy and implement key tasks, and jointly set up a cross-regional joint procurement office for drug centralized procurement agencies in the alliance region to carry out centralized drug procurement on behalf of the medical institutions in the alliance region, and organize and supervise the implementation of the procurement results.
to further improve the normal and professional operation mechanism of centralized drug procurement by the state organization, the Shanghai Pharmaceutical Centralized Tendering and Procurement Service Management shall undertake the daily work of the joint procurement office of the state organization and be responsible for the specific implementation.
, the state, provinces and municipalities to carry out the national organization of some of the drugs through the consistent evaluation of centralized volume procurement, according to market conditions to carry out special procurement, guide the procurement work carried out in various places.
Provinces (autonomous regions and municipalities directly under the Central Government) carry out centralized belt procurement for medicines independent of the scope of centralized belt procurement by national organizations or form alliances with other provinces in the region, and guide the procurement work in the integrated areas at the municipal level with the conditions.
municipal co-ordination areas shall, in accordance with the arrangements of the provinces (autonomous regions and municipalities directly under the Central Government), carry out centralized belt procurement on drugs outside the scope of centralized belt procurement by higher-level organizations or form alliances with other regions.
for medicines that have not yet been included in the centralized procurement scope of government organizations, medical institutions may conduct procurement independently or by entrusting them on the provincial drug centralized procurement platform.
The General Office of the State Council on promoting the normal and institutionalized development of drug centralized belt procurement State Office issued (2021) No. 2 the people's governments of provinces, autonomous regions and municipalities directly under the Central Government, ministries and agencies under the State Council: drug centralized belt procurement is an important measure to jointly promote the reform of the supply side of pharmaceutical services.
the 19th National Congress of the COMMUNIST Party of China, in accordance with the decision-making and deployment of the CPC Central Committee and the State Council, the reform of drug centralized belt procurement has achieved remarkable results and played an important role in promoting people's livelihood and well-being, promoting the reform of the three-doctor association, and promoting the healthy development of the pharmaceutical industry.
in order to promote the normal institutionalization of drug centralized belt procurement work, with the consent of the State Council, the following views are put forward.
, the overall requirements (i) guiding ideology.
Guided by Xi Jinping's thought of socialism with Chinese characteristics in the new era, we will fully implement the spirit of the Second, Third, Fourth and Fifth Plenary Sessions of the 19th National Congress of the Communist Party of China, adhere to the people-centered development ideology, improve the market-oriented drug price formation mechanism, give full play to the strategic purchasing role of the health insurance fund, and promote the concentration of medicines. The normal institutionalization of quantity procurement is carried out, the working mechanism of government organizations, alliance procurement and platform operation is improved, the centralized procurement market for drugs is formed to be unified and open throughout the country, drug prices are guided back to a reasonable level, the burden of drug use by the masses is effectively reduced, the healthy development of the pharmaceutical industry is promoted, the reform of public medical institutions is promoted, and the people's medical treatment is better guaranteed.
(ii) basic principles.
is to adhere to the demand-oriented, quality first.
according to the needs of clinical drug use, combined with the medical insurance fund and patient affordability, reasonably determine the scope of centralized procurement of drugs, ensure the quality and supply of drugs, to meet the people's basic medical needs.
second is to adhere to market-led, promote competition.
establish an open and transparent market competition mechanism, guide enterprises to carry out fair competition based on cost and quality, and improve the market price discovery mechanism.
third is to insist on the recruitment of one, volume price linkage.
to clarify the amount of procurement, to volume exchange prices, ensure the use, smooth procurement, use, settlement and other links, effective treatment of drug rebates.
fourth is to adhere to policy convergence, departmental coordination.
Improve the supporting policies of drug quality supervision, production and supply, circulation and distribution, medical services, medical insurance payment, market supervision, strengthen sectoral linkage, pay attention to the reform of system integration, coordination and efficiency, and support and promote each other with the centralized drug procurement system.
, clear coverage (iii) the scope of drugs.
In accordance with the principle of basic and clinical protection, the focus will be on the basic medical insurance drug catalog of large quantities of drugs, high procurement amount of drugs into the procurement scope, and gradually cover the domestic market clinically necessary, reliable quality of all kinds of drugs, so that should be harvested.
priority should be given to the procurement of drugs that have been evaluated for the quality and efficacy of generic drugs (including the same as between) and the same technology (hereinafter referred to as consistency evaluation).
quantity or amount of qualified drugs, i.e. to initiate centralized strip procurement.
actively explore the appropriate procurement methods for "orphan medicine" and shortage of medicines to promote the stability of supply.
(iv) the scope of the enterprise.
A listed license holder who has obtained a drug registration certificate within the scope of centralized volume procurement (if the drug listing license holder is an overseas enterprise, and the enterprise legal person in China who has been designated by him to perform the obligations of the drug listing license holder in accordance with the Drug Administration Law of the People's Republic of China) who has met the requirements for centralized volume procurement in terms of quality standards, production capacity and supply stability may participate in principle.
enterprises participating in centralized volume procurement should make commitments to the quality and supply of medicines.
(v) the scope of medical institutions.
all public medical institutions (including military medical institutions, the same between those referred to between) shall participate in the centralized procurement of medicines, and the medical insurance fixed-point social-run medical institutions and fixed-point pharmacies shall be carried out in accordance with the requirements of the management of fixed-point agreements.
, improve the procurement rules (6) reasonable determination of the amount of procurement.
of drug procurement is approved according to the demand reported by medical institutions, combined with the previous year's usage, clinical use and medical technology progress.
the proportion of procurement is reasonably determined according to the characteristics of clinical use of drugs, the pattern of market competition and the number of selected enterprises, and is improved as far as possible under the premise of ensuring quality and supply and preventing monopoly.
agreed procurement volume is determined according to the procurement volume base and the agreed procurement ratio and is disclosed in the procurement instrument.
public medical institutions are encouraged to purchase selected products in excess of the agreed amount of medicines in real terms, and other appropriately priced registered varieties can also be purchased through the provincial drug centralized procurement platform.
(7) improve the rules of competition.
No quality grouping is set for generics, original research drugs and parameterization preparations that have been evaluated by consistency, and centralized volume procurement is carried out directly under the generic name Competition Unit, and no protective or discriminatory provisions shall be set up.
to the consistent evaluation of drug varieties not yet covered, we should clarify the procurement quality requirements, explore the establishment of a comprehensive evaluation system based on big data for clinical use, with generic drug grouping in principle not more than 2.
in accordance with the reasonable price relationship, the clinical efficacy of similar drugs with the generic name of the same route of administration of different dosage forms, specifications, packaging and its procurement volume combined to promote competition.
to explore the integration of different generic drugs with similar allergies or functional treatments for centralized volume procurement.
more than 3 generic drugs are evaluated by consistency, the centralized volume procurement will no longer select products that have not passed the conformity evaluation under the premise of ensuring supply.
(eight) optimize the selection rules.
to determine the maximum effective declared price of the purchased drug based on the existing market price and other finalists.
according to market competition pattern, supply capacity to determine the number of selected enterprises, reflecting the scale effect and effective competition.
enterprises to participate voluntarily, independent quotations.
to produce the selected enterprise and the selected price through quality and price competition.
results should reflect the principle of volume price linkage, clear the enterprise's agreed procurement volume.
the price difference between the two countries and the generic name drug has more than one home-selected enterprise.
the purchase agreement period according to the number of selected enterprises.
(9) strictly abide by the agreement.
parties shall strictly abide by laws and regulations and agreements, implement the results of the election, enjoy their rights, fulfill their obligations and assume corresponding responsibilities in accordance with the law.
After the end of the procurement agreement, we should focus on stabilizing market expectations, stabilizing price levels, stabilizing clinical drug use, taking into account such factors as reliable quality, supply stability, good credit, clinical demand, adhere to the integration of recruitment, quantity price linkage, determine supply enterprises in accordance with the law, agreed procurement volume and purchase agreement period;
, strengthen safeguard measures (10) to strengthen quality assurance.
strict drug quality entry standards, strengthen the selection of enterprises to ensure product quality of the main responsibility.
Implement the responsibility of local government territory supervision, include the selected drugs in the key regulatory varieties, and strengthen the quality supervision of the whole chain of production, circulation and use in accordance with the requirements of "the most stringent standards, the strictest supervision, the most severe punishment and the most serious accountability".
medical institutions should strengthen the monitoring of adverse reactions to selected drugs and report suspected adverse reactions in a timely manner according to procedures.
improve the mechanism of coordination and supervision of information communication between departments, accelerate the construction of the whole process of traceability system for the production and circulation of drugs, and basically realize that the whole process of selecting drugs can be queried and traceable.
the quality of medicines in accordance with the law.
(11) to do a good job of supply and distribution.
selected enterprises should do a good job in market risk forecasting and prevention, organize drug production in accordance with procurement contracts, report on production capacity, inventory and supply according to requirements, and ensure that the procurement needs of selected drugs in medical institutions are met in a timely manner during the procurement cycle.
the selected drugs shall be independently commissioned by the selected enterprise for distribution or self-distribution, and the distribution costs shall be borne by the selected enterprise.
the distribution party should have the corresponding qualifications for drug distribution and complete drug circulation traceability system, have the ability to cover the agreement supply area, timely response to medical institutions purchase orders and distribution in place.
strengthen distribution guarantees in remote areas.
the failure to supply in a timely manner, except for force maje force factors, the selected enterprise shall bear the corresponding liability and all the costs incurred thereof, otherwise it shall be regarded as a breach of trust.
(12) ensure priority use.
medical institutions shall give priority to the use of the selected drugs in accordance with the needs of clinical drug use and complete the agreed purchase amount in accordance with the procurement contract.
medical institutions in the doctor's prescription information system to set priority to recommend the selection of centralized band procurement varieties of procedures, clinicians in accordance with the generic name of prescription, pharmacy personnel to strengthen prescription review and deployment.
the procurement and use of selected medicines by medical institutions into the performance of public medical institutions